BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS

    MDR report key: 7748234 · Received August 3, 2018

    Report

    Report Number
    1823260-2018-02600
    Event Type
    Malfunction
    Date Received
    August 3, 2018
    Date of Event
    June 26, 2018
    Report Date
    August 3, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFZ
    UDI-DI
    04015630923489
    PMA / PMN Number
    K131605
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF FALSE POSITIVE ELECSYS CMV IGG ASSAY RESULTS FOR 1 PATIENT SAMPLE ON THE COBAS 8000 E 801 MODULE. THE E 801 MODULE SERIAL NUMBER WAS ASKED FOR NOT PROVIDED. THE INITIAL CMV IGG RESULT WAS >500 U/ML. USING A DIFFERENT SAMPLE TUBE FROM THE SAME BLOOD COLLECTION, THE CMV IGG RESULTS WERE 492 U/ML, 490 U/ML, 487 U/ML, AND 428 U/ML. THE CMV IGG RESULT WAS < 4 UA/ML WITH THE VIDAS BIOMERIEUX METHOD. IT WAS NOT CLEAR WHICH SAMPLE TUBE WAS USED. ON (B)(6) 2018 A NEW SAMPLE WAS COLLECTED AND THE CMV IGG RESULT WAS 500 U/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED WITH A 1:20 DILUTION AND THE CMV IGG RESULT WAS 437 U/ML. THE CMV IGG REAGENT LOT NUMBER WAS 252325 WITH AN EXPIRATION DATE OF 30-SEP-2018. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE SAMPLE WAS PROVIDED FOR INVESTIGATION AND THE RESULT WAS NON-REACTIVE. THE CUSTOMER'S CMV IGG RESULT WAS NOT CONFIRMED. THE PROVIDED QC DATA WAS ACCEPTABLE. A GENERAL REAGENT ISSUE WAS EXCLUDED. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590749 CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS LFZ ROCHE DIAGNOSTICS NA 252325 04015630923489

    Patients

    Seq Age Sex Outcome Treatment
    1